Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study.

"Transparency declarations: P.F. received research grants (to his institution) from the French National Agency for AIDS Research (ANRS), consultancy fees from MSD France and honoraria and travel grants from ViiV Healthcare, Bristol-Myers Squibb, Janssen Cilag, Gilead Sciences and MSD France for participation in educational programmes and conferences. G.P. has received travel grants, consultancy fees, honoraria, or study grants from various pharmaceutical companies, including Gilead Sciences, Merck, Pfizer, Takeda, Theratechnologies and ViiV Healthcare. V.A.F. received research grants (to her institution) from the French National Agency for AIDS Research (ANRS), and honoraria and travel grants from ViiV Healthcare and Gilead Sciences for participation in educational programmes and conferences. The other authors report no conflicts of interest regarding this work.: Author contributionsLaurent Mandelbrot: conceptualization, investigation, writing, funding acquisition; Roland Tubiana: conceptualization, investigation, writing; Pierre Frange: investigation, writing; Gilles Peytavin: investigation, analysis, writing; Jerome Le Chenadec: data management, formal analysis; Ana Canestri: investigation; Philippe Morlat: investigation, editing; Cécile Brunet-Cartier: investigation; Jeanne Sibiude: investigation, writing, analysis; Delphine Peretti: investigation; Véronique Chambrin: investigation; Amélie Chabrol: investigation; Eida Bui: investigation; Caroline Simon-Toulza: investigation; Lucie Marchand: supervision; Christelle Paul: supervision; Sandrine Delmas: project administration; Véronique Avettand-Fenoel: investigation, analysis; Josiane Warszawski: methodology, validation, analysis."

"Funding This work was supported by the Agence Nationale de Recherches sur le Sida et les Hépatites Virales/Maladies Infectieuses Emergentes for research on AIDS, viral hepatitis and Emerging infectious diseases (Study number ANRS-168)."

"All women were enrolled with their informed, written consent. The trial was registered (EudraCT # 2015-002542-31, Clinicaltrials.gov #NCT02738502) and was approved by the Committee for Protection of Persons (CPP Ile de France VII) on 22 January 2016 and the French Medicines Agency on 17 December 2015."